Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery

Multimodal Analgesia Pathway Assessing Role of Suzetrigine for the Reduction of Opioid Use Following Ureteroscopic Surgery

Urologic surgery has advanced with new technologies to allow less invasive management of common afflictions such as kidney stones, these procedures are notoriously painful as the ureter must be dilated to accommodate any instruments, and a ureteral stent is often left following surgery to allow for adequate healing. Unfortunately, stents are poorly tolerated by a significant number of patients, with up to 100% complaining of bothersome pain and 10% of patients with unplanned healthcare visits. Further complicating kidney stone management is the frequency of concurrent chronic kidney disease (CKD) or acute kidney injury (AKI) that prohibits many patients from taking NSAIDs which limits pain management options. There is now a push to treat these patients with multimodal analgesia to provide better care and reduce opioid use. Suzetrigine is a new a first-in-class selective inhibitor of the NaV1.8 sodium channel that functions as a non-opioid analgesic developed to treat acute pain and neuropathic pain. This study assesses the addition of suzetrigine to standard-of-care multimodal analgesia. We hypothesize a demonstrated decrease in opioid use, decrease Emergency Room visits within 30 days, decrease the number of unplanned care encounters.

Study Overview

• Status: Not yet recruiting
• Conditions: Multimodal Analgesia; Ureteroscopy; Opioid Consumption, Postoperative; Ureteral Stent-Related Symptoms; Ureteral Stents
• Intervention / Treatment: Drug: multimodal analgesia regimen without suzetrigine; Drug: Suzetrigine

Detailed Description

Urologic surgery has advanced with new technologies to allow less invasive management of common afflictions such as kidney stones, these procedures are notoriously painful as the ureter must be dilated to accommodate any instruments, and a ureteral stent is often left following surgery to allow for adequate healing. Unfortunately, stents are poorly tolerated by a significant number of patients, with up to 100% complaining of bothersome pain and 10% of patients with unplanned healthcare visits. Further complicating kidney stone management is the frequency of concurrent chronic kidney disease (CKD) or acute kidney injury (AKI) that prohibits many patients from taking NSAIDs which limits pain management options. There is now a push to treat these patients with multimodal analgesia to provide better care and reduce opioid use. Suzetrigine is a new a first-in-class selective inhibitor of the NaV1.8 sodium channel that functions as a non-opioid analgesic developed to treat acute pain and neuropathic pain. This study assesses the addition of suzetrigine to standard-of-care multimodal analgesia. We hypothesize a demonstrated decrease in opioid use, decrease Emergency Room visits within 30 days, decrease the number of unplanned care encounters. This prospective open-label interventional single-center study will compare 30-day postoperative patient reported outcomes and pain medication use between a pre-implementation cohort of patients managed with standard-of-care multimodal analgesia after ureteroscopy with a post-implementation cohort of patient with this regimen and addition of suzetrigine. The primary outcome will be opioid usage after discharge with standard of care multimodal analgesia (historical control) vs opioid usage after discharge with suzetrigine included with the standard of care

multimodal analgesia regimen (intervention). Secondary outcomes will include unplanned care encounters within 30 days (Emergency Room, unplanned clinic visits) and surveyed patient reported outcomes measured on a post-operative survey including PROMIS (Patient-Reported Outcomes Measurement Information System) questions as well as an end of study administration of WISQOL (The Wisconsin Stone Quality of Life Questionnaire). The study will be conducted within a single academic institution including the primary hospital (Brigham and Women's Hospital) and satellite sites (Brigham and Women's Faulkner Hospital).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Daniel A Wollin, MD, MS; Phone Number: 617 732 6354; Email: dwollin@mgb.org
• Study Contact Backup: Name: Christopher Magnani, MD, MS, MPhil; Email: CMAGNANI@BWH.HARVARD.EDU

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
      • Contact: Daniel A Wollin, MD, MS; Phone Number: 617 732 6354; Email: dwollin@mgb.org
    • Boston, Massachusetts, United States, 02130
      • Brigham and Women's Faulkner Hospital
      • Contact: Daniel A Wollin, MD, MS; Phone Number: 617 732 6354; Email: dwollin@mgb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing ureteroscopy between ages 21 to 80 at BWFH (Brigham & Women's Faulkner Hospital) by one of the department's high volume endoscopic surgeons. Patient who are or not pre-stented prior to surgery will be included (these will be assessed via stratification within a secondary analysis).
• Patients able to consent for their own medical care (i.e. consent able to be obtained directly from patient and does not require a healthcare proxy or guardian)

Exclusion Criteria:

• Regular opioid use prior to surgery or significant substance abuse concerns.
• Inability of patient to provide their own consent (i.e. lack capacity).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: multimodal analgesia pathway (standard, no suzetrigine); multimodal analgesia pathway without suzetrigine	Drug: multimodal analgesia regimen without suzetrigine; multimodal analgesia regimen
Experimental: suzetrigine with multimodal analgesia pathway; addition of suzetrigine to multimodal analgesia pathway	Drug: Suzetrigine; suzetrigine with multimodal analgesia regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-discharge opioid consumption (MME)	assessed at post-operative visit	1-2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-discharge opioid consumption (MME)	assessed at 30 days after surgery	30 days
Rate of unplanned care encounters	Emergency Room visits	30 days
patient reported outcomes: pain score	measured on a 0 to 10 analog scale on post-operative survey	2 weeks
patient reported outcomes: pain score	measured on a 0 to 10 analog scale on post-operative survey	30 days
patient reported outcomes: PROMIS composite score	total score where each of the following is rated from 0 to 4 then aggregated into a total value: How much did pain interfere with your day-to-day activities?; How much did pain interfere with work around the home?; How much did pain interfere with your ability to participate in social activities?; How much did pain interfere with your household chores?; How much did pain interfere with things you usually do for fun?; How much did pain interfere with your enjoyment of social activities?	2 weeks
patient reported outcomes: PROMIS composite score	total score where each of the following is rated from 0 to 4 then aggregated into a total value: How much did pain interfere with your day-to-day activities?; How much did pain interfere with work around the home?; How much did pain interfere with your ability to participate in social activities?; How much did pain interfere with your household chores?; How much did pain interfere with things you usually do for fun?; How much did pain interfere with your enjoyment of social activities?	30 days
patient reported outcomes (PROMIS) pain interfere with your day-to-day activities	rated from 0 to 4	2 weeks
patient reported outcomes (PROMIS) pain interfere with your day-to-day activities	rated from 0 to 4	30 days
patient reported outcomes (PROMIS) pain interfere with work around the home	rated from 0 to 4	2 weeks
patient reported outcomes (PROMIS) pain interfere with work around the home	rated from 0 to 4	30 days
patient reported outcomes (PROMIS) pain interfere with your ability to participate in social activities	rated from 0 to 4	2 weeks
patient reported outcomes (PROMIS) pain interfere with your ability to participate in social activities	rated from 0 to 4	30 days
patient reported outcomes (PROMIS) pain interfere with your household chores	rated from 0 to 4	2 weeks
patient reported outcomes (PROMIS) pain interfere with your household chores	rated from 0 to 4	30 days
patient reported outcomes (PROMIS) pain interfere with things you usually do for fun	rated from 0 to 4	2 weeks
patient reported outcomes (PROMIS) pain interfere with things you usually do for fun	rated from 0 to 4	30 days
patient reported outcomes (PROMIS) pain interfere with your enjoyment of social activities	rated from 0 to 4	2 weeks
patient reported outcomes (PROMIS) pain interfere with your enjoyment of social activities	rated from 0 to 4	30 days

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ureteroscopy; Postoperative Opioid Consumption; Multimodal Analgesia; ureteral stents
• Other Study ID Numbers: 2026P000126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This trial is being performed at within a single institution (Mass General Brigham) at two of it's constituent sites (BWH and BWFH), as part of IRB approval of the study decision was for privacy policy that only aggregated data would be intended to be shared outside the institutions system and any IPD would be solely stored on HIPAA compliant servers at the facility. De-identified or aggregated data would be permitted to be shared so long as subjects could not be identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No